FDA Approves Expansion of Edwards Sapien XT Trial

November 10, 2011 — Edwards Lifesciences Corp. announced the U.S. Food and Drug Administration (FDA) conditionally approved the addition of a second treatment group to the PARTNER II Trial. The trial is studying the company's next-generation Edwards Sapien XT transcatheter heart valve.

This new cohort (Cohort A) of the trial is a non-inferiority study of up to 2,000 patients with severe, symptomatic aortic valve stenosis who have an elevated risk for traditional open-heart surgery (Society of Thoracic Surgeons score >4). This is a lower risk profile than those who were enrolled in the PARTNER trial.

Patients will be evenly randomized to receive the Sapien XT valve or surgery. Those undergoing transcatheter valve replacement will be treated either transfemorally (via the femoral artery) or transapically (via a small incision between the ribs). The primary endpoint for evaluation is a composite of death and major stroke at two years, with secondary endpoints that include valve performance and quality-of-life indicators.

"Based on the favorable outcomes in the PARTNER trial, we are pleased to be able to study our next-generation valve platform in an expanded patient population that can benefit from a less-invasive therapy," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "The success of this trial would support the use of the transcatheter therapy in a broader group of patients."

The company hopes to complete enrollment in the first cohort (Cohort B) of this trial around year-end. Data from this cohort of inoperable patients is intended to support United States commercial approval of the Sapien XT valve.

The device is commercially available in Europe, where it received a CE Mark in March 2010. It is an investigational device in the U.S. and is not yet available commercially.